FDA.reportPublic FDA data

Ibuprofen and Diphenhydramine Citrate

Product NDC
21130-228
11-digit product format
211300228
Labeler code
21130
Product ID
21130-228_09fc3572-d282-478d-ba22-70690f615e65
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen and Diphenhydramine Citrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Better Living Brands, LLC
Application
ANDA216204
Marketing category
ANDA
Marketing start
2023-11-15
Substance
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength
38; 200 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen and Diphenhydramine Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE CITRATE38 mg/1
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4OD433S209, WK2XYI10QM
Rxcui895664

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-228-12Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED13
21130-228-12Ibuprofen and Diphenhydramine Citrate40 in 1 BOTTLETABLET, COATED403
21130-228-18Ibuprofen and Diphenhydramine Citrate80 in 1 BOTTLETABLET, COATED803
21130-228-18Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED13
21130-228-23Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED13
21130-228-23Ibuprofen and Diphenhydramine Citrate120 in 1 BOTTLETABLET, COATED1203
21130-228-73Ibuprofen and Diphenhydramine Citrate1 in 1 CARTONTABLET, COATED13
21130-228-73Ibuprofen and Diphenhydramine Citrate20 in 1 BOTTLETABLET, COATED203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-228IBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET, COATED [BETTER LIVING BRANDS, LLC]3Current NDC, 8 package rows20241103_fcfb044d-f6b9-5c43-e053-6394a90ac417.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSNfcfb044d-f6b9-5c43-e053-6394a90ac4173
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCDfcfb044d-f6b9-5c43-e053-6394a90ac4173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-228-12211300228121 BOTTLE in 1 CARTON (21130-228-12) / 40 TABLET, COATED in 1 BOTTLE1 bottle2023-11-15NoNoCurrent
21130-228-18211300228181 BOTTLE in 1 CARTON (21130-228-18) / 80 TABLET, COATED in 1 BOTTLE1 bottle2023-11-15NoNoCurrent
21130-228-23211300228231 BOTTLE in 1 CARTON (21130-228-23) / 120 TABLET, COATED in 1 BOTTLE1 bottle2023-11-15NoNoCurrent
21130-228-73211300228731 BOTTLE in 1 CARTON (21130-228-73) / 20 TABLET, COATED in 1 BOTTLE1 bottle2023-11-15NoNoCurrent